Business Wire

Data of Chugai's Alecensa® Presented at the American Society of Clinical Oncology on Global Phase III ALEX Study

Del

Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that the results of the global phase III study (the ALEX study) of Alecensa®, conducted by F. Hoffmann-La Roche Ltd., in ALK fusion gene positive non-small cell lung cancer (NSCLC) patients, will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO) held in Chicago. The presentation will be held on oral abstract sessions on 6th June (Tue) 12:09-12:21 (CDT) as a late breaking subject.

Abstract LBA9008
Alectinib versus crizotinib in treatment-naive advanced ALK-positive non-small cell lung cancer (NSCLC): Primary results of the global phase III ALEX study.

“In the ALEX study comparing the efficacy and safety of first line therapy of Alecensa with crizotinib, Alecensa showed a significant prolongation of PFS and reduced the risk of disease progression by 84% in patients with brain metastasis. The study also showed that Alecensa was well tolerated. These results will encourage the patients to fight cancer,” said Dr. Yasushi Ito, Senior Vice President, Head of Project & Lifecycle Management Unit. “We believe that Alecensa will also contribute to improving the outcomes of many ALK fusion gene positive NSCLC patients not just in Japanese but overseas.”

The ALEX study was an open-label, randomized global phase III study that compares the efficacy and safety between Alecensa and crizotinib in the first line therapy. The ALEX study enrolled treatment-naïve 303 patients with ALK fusion gene positive NSCLC. The subjects were allocated to either the Alecensa arm or the crizotinib arm in a one to one ratio. The primary endpoint of the ALEX study was PFS as assessed by the investigator. The secondary endpoints included independent review committee (IRC)-assessed PFS, IRC-assessed time to CNS progression, objective response rate, overall survival, safety and other endpoints.

Summaries of the ALEX study results
Efficacy:

- At the primary data cut-off, Alecensa arm demonstrated statistically significant improvement superiority vs crizotinib arm, reducing risk of progression or death by 53% (HR=0.47, 95%CI: 0.34-0.65, stratified log-rank test, p<0.0001) by investigators’ assessment. Median PFS was not reached (95%CI: 17.7-not reached) in the Alecensa arm while it was 11.1 months (95%CI: 9.1-13.1) in the crizotinib arm.

- According to independent review committee, Alecensa arm demonstrated statistically significant improvement superiority vs crizotinib arm, reducing risk of progression or death by 50% (HR=0.50, 95%CI: 0.36-0.70). Median PFS was 25.7 months (95%CI: 19.9-not reached) in the Alecensa arm while it was 10.4 months (95%CI: 7.7-14.6) in the crizotinib arm.

- Alecensa arm demonstrated improvement vs crizotinib arm, reducing risk of CNS progression or death by 84% (HR=0.16, 95% CI: 0.10-0.28).

- Overall survival data are currently considered immature with only about a quarter of events being reported.

Safety:

- Grade 3-5 adverse events (AEs) were less frequent with Alecensa arm, 41%, vs 50% with crizotinib arm.

- No new safety findings were observed in either arm.

About Alecensa

Alecensa is a highly selective oral ALK inhibitor created by Chugai. It has been reported that approximately five percent of patients with NSCLC express a chromosomal rearrangement which leads to fusion of the ALK gene with another gene.1) ALK kinase signalling is constantly active in cells with such fusion genes, resulting in uncontrolled growth of tumour cells and transforming the cells into tumour cells. 2, 3) Alecensa exerts its anti-tumour effect by selectively inhibiting ALK kinase activity to inhibit tumour cell proliferation and induce cell death. 4) In addition, Alecensa is not recognized by the active efflux system in the blood brain barrier which actively pumps molecules out of the brain. Thus, Alecensa is able to remain active in the central nervous system and has proven activity against brain metastases.

Alecensa is currently approved in the United States, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, India, the EU, Australia, Taiwan and Singapore for the treatment of adult patients with ALK-positive, metastatic (advanced) NSCLC who have progressed on or those intolerant to crizotinib. In Japan, “Alecensa capsule 150mg” is available to patients with “ALK fusion gene positive unresectable, recurrent/advanced NSCLC” and is marketed by Chugai.

The approved dosage and administration in Japan is “300mg alectinib is administered orally twice daily for adult patient.”

1) Biomarker committee of The Japan Lung Cancer Society, Guidelines for ALK gene tests in lung cancer patients
2) Soda et al., Nature. 448: 561-566 (2007)
3) Takeuchi et al., Clin Cancer Res. 15: 3143-3149 (2009)
4) Sakamoto et al., Cancer Cell. 19: 679-690 (2011)

About Chugai

Chugai Pharmaceutical is one of Japan’s leading research-based pharmaceutical companies with strengths in biotechnology products. Chugai, based in Tokyo, specializes in prescription pharmaceuticals and is listed on the 1st section of the Tokyo Stock Exchange. As an important member of the Roche Group, Chugai is actively involved in R&D activities in Japan and abroad. Specifically, Chugai is working to develop innovative products which may satisfy the unmet medical needs, mainly focusing on the oncology area.
In Japan, Chugai’s research facilities in Gotemba and Kamakura are collaborating to develop new pharmaceuticals and laboratories in Ukima are conducting research for technology development for industrial production. Overseas, Chugai Pharmabody Research based in Singapore is engaged in research focusing on the generation of novel antibody drugs by utilizing Chugai’s proprietary innovative antibody engineering technologies. Chugai Pharma USA and Chugai Pharma Europe are engaged in clinical development activities in the United States and Europe.
The consolidated revenue in 2016 of Chugai totalled 491.8 billion yen and the operating income was 80.6 billion yen (IFRS Core basis).
Additional information is available on the internet at https://www.chugai-pharm.co.jp/english.

Contact information

For Media
Chugai Pharmaceutical Co., Ltd.
Media Relations Group, Corporate Communications Dept.,
Koki Harada
Tel: +81-3-3273-0881
E-mail: pr@chugai-pharm.co.jp
***
For US media
Chugai Pharma USA Inc.
Casey Astringer
Tel: +1-908-516-1350
E-mail: pr@chugai-pharm.com
***
For European media
Chugai Pharma France SAS
Nathalie Leroy
Tel: +33-1-56-37-05-21
E-mail: pr@chugai.eu
***
For Taiwanese media
Chugai Pharma Taiwan Ltd.
Susan Chou
Tel: +886-2-2715-2000
E-mail: pr@chugai.com.tw
***
For Investors
Chugai Pharmaceutical Co., Ltd.
Investor Relations Group, Corporate Communications Dept.,
Toshiya Sasai
Tel: +81-3-3273-0554
E-mail: ir@chugai-pharm.co.jp

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Rimini Street Expands Investment and Operations in Europe18.10.2017 22:00Pressemelding

Rimini Street, Inc., (Nasdaq: RMNI), a global provider of enterprise software products and services, and the leading third-party support provider for Oracle and SAP software products, today announced the appointment of industry leader Marc Chesover as general manager of Europe, the Middle East and Africa (EMEA). The Company also announced the launch of its French subsidiary, hiring of new staff and opening of its new office in Paris, France. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171018006654/en/ Rimini Street Expands Investment and Operations in Europe (Photo: Business Wire) Enterprise Software Veteran Leads EMEA Operations Rimini Street’s new general manager, Marc Chesover, will lead the Company’s sales and service delivery operations across EMEA, and the next p

Kite’s Yescarta™ (Axicabtagene Ciloleucel) Becomes First CAR T Therapy Approved by the FDA for the Treatment of Adult Patients With Relapsed or Refractory Large B-Cell Lymphoma After Two or More Lines of Systemic Therapy18.10.2017 21:43Pressemelding

Kite, a Gilead Company, (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted regular approval to Yescarta™ (axicabtagene ciloleucel), the first chimeric antigen receptor T cell (CAR T) therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma, or TFL). Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171018006639/en/ CAR T therapy is a breakthrough in hematologic cancer treatment in which

IFF Launches Re-Imagine…™ Programs to Tap Unmet Consumer Opportunities, Speed Innovation18.10.2017 20:15Pressemelding

Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris:IFF), a leading innovator of sensory experiences that move the world, launched their Re-Imagine programs to accelerate innovation and increase agility to capture unmet opportunities in the changing food and beverage market. Based on a combination of future trends analysis, consumer insights, and a modernized cross-category development process, the programs guide the Company’s research and development efforts to ensure an innovation pipeline that addresses evolving consumer needs and desires. “The Re-Imagine programs area tangible expression of our commitment to advance taste for our customers – and consumers,” said IFF Chairman and CEO Andreas Fibig. “It is another way in which we show how we are dedicated to being our customers’ partner of choice as we progress on our business strategy, imbu

Sparkol Launches VideoScribe 318.10.2017 13:24Pressemelding

Introducing VideoScribe Version 3 by Sparkol. Already used by over two million people across the world to create engaging explainer videos, Version 3 of the highly intuitive software comes packed full of new features, including: An improved user experience and slick UI - animate easier than ever before Enhanced search - find exactly the image you need in record time Intelligent image recommendations - focus your creativity on your video instead Smoother performance - maximum productivity when using the software VideoScribe customers include the world’s largest brands (HP, BBC, Sky and the University of British Columbia), businesses across every sector, leading education providers, award-winning teachers, charities, campaigners, and coun

Piraeus Bank: Agreement for the Sale of Serbian Operations18.10.2017 13:06Pressemelding

Piraeus Bank announces that it has entered into an agreement to sell its Serbian banking and leasing operations to Direktna Banka A.D., a local Serbian banking group that has been strongly growing its presence in the market, for a total cash consideration between €58mn up to €61mn, depending on the financial performance of the divested assets until completion of the transaction, through a combination of direct sale price and simultaneous reduction of capital in Piraeus Bank Beograd AD. The transaction is conditional upon the usual corporate and regulatory approvals, including those of the National Bank of Serbia and the Hellenic Financial Stability Fund. The transaction represents another step towards the implementation of Piraeus Bank’s Restructuring Plan commitments, as those were agreed with the Directorate General of Competition of the European Commission. The transactio

Introducing InVision Studio, The World’s Most Powerful Screen Design Tool18.10.2017 13:01Pressemelding

InVision, the product design platform powering the world’s best digital experiences, today introduced Studio, a powerful new tool that will change the way screen design is done. InVision Studio was created by working closely with the world’s best design teams and finding inspiration in how they create beloved digital products. The launch of Studio comes at a time when modern organizations are shaping and redefining entire markets through their focus on digital customer experience. InVision already powers the product design process of more than 3 million people at tens of thousands of companies, including eighty percent of the Fortune 100 and brands like Airbnb, Uber, HBO, Amazon, IBM, Nike, and Slack. This new product reflects a major evolution of the digital product design workflow. With Studio, InVision has developed an end-to-end platform for designing digit

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom